Implant Delivery Device

ABSTRACT

An implant delivery device may include an implant holding portion proximate the distal end, the implant holding portion being configured to retain a sheet-like implant during implantation of the implant. In addition, the implant holding portion may be configured to receive the implant with a fixed implant supporting flange member configured to support the implant on one side, and a movable implant supporting flange member. The movable implant supporting flange member may be configured to be slidable between a distal position and a proximal position, wherein, in the distal position, the movable implant supporting flange member and secures the implant against the fixed implant supporting flange member, and in the proximal position, the movable implant supporting flange member is withdrawn from the distal end of the implant delivery device, thus enabling release of the implant.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.17/174,011, filed Feb. 11, 2021, and entitled “Implant Delivery Device”,which claims the benefit of Provisional Patent Application No.62/972,775, filed on Feb. 11, 2020, and entitled “Graft DeliveryDevice,” the entire disclosure of which is hereby incorporated byreference.

BACKGROUND

The present embodiments relate generally to medical devices, and inparticular to medical devices used to repair tissue.

Rotator cuff repair is a surgical procedure performed to repair torn (orpartially torn) tendons in the shoulder. This procedure can be done withlarge incisions or with arthroscopic techniques. To repair a torn tendon(such as the supraspinatus tendon), a surgeon may use anchors andsutures to reattach the tendon to the humerus bone. The repaired areamay then be covered with a graft to facilitate healing. Inserting agraft through a small incision and laying it down in a desired positioncan be difficult with arthroscopic surgery.

There is a need in the art for a system and method that addresses theshortcomings discussed above.

SUMMARY

In one aspect, the present disclosure is directed to an implant deliverydevice including a handle disposed at a proximal end of the implantdelivery device and configured to be grasped by a user. The device mayfurther include an outer shaft extending from the handle to a distal endof the implant delivery device. In addition, the implant delivery devicemay include an implant holding portion proximate the distal end of theimplant delivery device, the implant holding portion being configured toretain a sheet-like implant during implantation of the implant. Further,the implant holding portion may be configured to receive the implantbetween a fixed implant supporting flange member and configured tosupport the implant on one side, and a movable implant supporting flangemember. The movable implant supporting flange member may be configuredto be slidable between a first, distal position and a second, proximalposition. In the first, distal position, the movable implant supportingflange member secures the implant against the fixed implant supportingflange member, thus holding the implant in an unfurled configuration. Inthe second, proximal position, the movable implant supporting flangemember is withdrawn from the distal end of the implant delivery device,thus enabling release of the implant.

In another aspect, the present disclosure is directed to an implantdelivery device including an implant holding portion proximate a distalend of the implant delivery device, the implant holding portion beingconfigured to retain a sheet-like implant during implantation of theimplant. The implant holding portion may be configured to receive theimplant with a movable implant supporting flange member configured toretain the implant. The movable implant supporting flange member may beconfigured to be movable between a first position in which the movableimplant supporting flange member holds the implant within the recess anda second position in which the implant is unencumbered by the movableimplant supporting flange member, thus enabling release of the implantfrom the implant holding portion of the implant delivery device.

In another aspect, the present disclosure is directed to a method ofdelivering a sheet-like implant to a surgical site. The method mayinclude providing an implant delivery device with a sheet-like implantsecured by an implant holding portion of the implant delivery devicesuch that the implant is held with respect to an outer shaft and betweena fixed implant supporting flange member and a movable implantsupporting flange member. The method may also include inserting theimplant holding portion of the implant delivery device to a surgicalsite. Further, the method may include moving the movable implantsupporting flange member to a second position, thereby allowing theimplant to be released.

Other systems, methods, features, and advantages of the embodiments willbe, or will become, apparent to one of ordinary skill in the art uponexamination of the following figures and detailed description. It isintended that all such additional systems, methods, features, andadvantages be included within this description and this summary, bewithin the scope of the embodiments, and be protected by the followingclaims.

BRIEF DESCRIPTION OF THE DRAWINGS

The embodiments can be better understood with reference to the followingdrawings and description. The components in the figures are notnecessarily to scale, emphasis instead being placed upon illustratingthe principles of the embodiments. Moreover, in the figures, likereference numerals designate corresponding parts throughout thedifferent views.

FIG. 1 is a schematic view of a step in a procedure for repairing arotator cuff tendon according to an embodiment;

FIG. 2 is a schematic view of a step of applying an implant to a portionof a rotator cuff tendon to facilitate healing according to anembodiment;

FIG. 3 is a schematic illustration of an implant delivery deviceaccording to an embodiment holding an implant prior to delivery throughan illustrated access cannula;

FIG. 4 is an enlarged schematic view of an implant holding portion ofthe implant delivery device holding an implant;

FIG. 5 is another schematic view of an implant delivery device accordingto an embodiment holding an implant prior to delivery through anillustrated access cannula;

FIGS. 6-7 are schematic views showing the implant being inserted throughthe cannula;

FIG. 8 is a schematic view of the implant being rolled up as it isduring delivery through the cannula, but with the cannula removed forpurposes of illustration;

FIG. 9 is a schematic view of the implant delivery device extendingthrough the cannula with the cannula sealing member seated within thecannula and with the implant unfurled after exiting the cannula;

FIG. 10 is a schematic view of the implant delivery device with animplant supporting flange member partially withdrawn part way throughthe process of releasing the implant;

FIG. 11 is an enlarged schematic view of the implant holding portion ofthe implant delivery device with the implant supporting flange memberpartially withdrawn, as shown in FIG. 10;

FIG. 12 is another enlarged schematic view of the implant holdingportion of the implant delivery device with the implant supportingflange member partially withdrawn;

FIG. 13 is another enlarged schematic view of the implant holdingportion of the implant delivery device with the implant supportingflange member partially withdrawn and with the implant shown in phantomin order to illustrate a second implant supporting member under theimplant;

FIG. 14 is an enlarged schematic view of the implant holding portion ofthe implant delivery device with the implant supporting flange memberpartially withdrawn and with the implant omitted in order to illustratethe relationship between the two implant supporting flange members;

FIG. 15 is a schematic views of an inner shaft and a movable implantsupporting flange member held therein;

FIG. 16 is a schematic view of the implant holding portion of theimplant delivery device with the implant supporting flange member fullywithdrawn and with the implant released from the implant deliverydevice;

FIG. 17 is a schematic view of the implant delivery device beingwithdrawn through the cannula after having delivered the implant;

FIG. 18 is a schematic view of the handle of the implant delivery devicewith an outer panel removed to reveal the inner components of thehandle;

FIG. 19 is a schematic view of the implant delivery device beingwithdrawn through the cannula with the cannula shown in phantom toreveal the ring on the outer shaft of the implant delivery devicepulling the cannula seal member out of the cannula; and

FIG. 20 is a flowchart illustrating a method of delivering a sheet-likeimplant to a surgical site using the implant delivery device shown anddiscussed with respect to FIGS. 3-19.

DETAILED DESCRIPTION

For clarity, the description makes reference to distal and proximaldirections (or portions). As used herein, the term “distal” shall referto a direction or portion oriented or located away from a user who isholding the implant delivery device (i.e., away from a surgeon using thedevice and toward a patient into which the device is being inserted).The term “proximal” shall refer to a direction or portion oriented orlocated toward a user who is holding the implant delivery device (i.e.,toward a surgeon using the device and away from a patient into which thedevice is being inserted).

In addition, as used herein, the term “fixedly attached” shall refer totwo components joined in a manner such that the components may not bereadily separated (for example, without destroying one or bothcomponents). The term “removably attached” shall refer to componentsthat are attached to one another in a readily separable manner (forexample, with fasteners, such as bolts, screws, etc.).

FIG. 1 is a schematic view illustrating a surgical procedure to repair atendon in a patient's shoulder. Specifically, a patient 100 isundergoing arthroscopic surgery that is performed by surgeon 102. Alsoshown in FIG. 1 is an enlarged view of a portion of humerus 110 androtator cuff tendons 112. In the present example, surgeon 102 hasrecently applied anchors and sutures to secure supraspinatus tendon 114to humerus 110.

Once the tendon has been sufficiently repaired and/or the surgical siteis otherwise prepared, surgeon 102 may insert an implant, such as agraft, through an incision (possibly using another device to facilitateinsertion). The graft can then be placed over the tendon and/or portionof the underlying bone in order to facilitate healing. As an example,FIG. 2 shows a schematic view of a graft 202 that has been applied overthe tendon 114 as well as over a portion of humerus 110.

Although the exemplary embodiment depicts a procedure in which a tendonis first secured to the bone using sutures and anchors, in otherembodiments a graft can be applied to one or more tendons without firstreattaching a tendon. For example, grafts could be applied to tendonsthat have only partial tears.

Once graft 202 has been placed over the tendon, one or more sutures oranchors are required to hold graft 202 in place. The present embodimentsdisclose a graft delivery device configured to hold an implant, such asa graft, during insertion and release the implant/graft once it has beensecured at the surgical site.

An embodiment of an implant delivery device that can be used to insertan implant through a small incision and position it in over tissue in afully opened condition is shown in FIGS. 3-19.

The implant delivery device may include provisions for biasing asheet-like implant to an open, unfurled configuration as well as forreleasing the implant once it has been placed in a desired location. Thehandle includes provisions to actuate components of an implant holdingportion of the device. It will be understood that the disclosed implantdelivery device may be configured to deliver any type of sheet-likeimplant. For example, in some embodiments, the delivery device may beused to deliver a sheet-like graft. In some embodiments, the graft maybe formed, at least in part of collagen. In other embodiments, thesheet-like implant may be formed of synthetic material or blends ofcollagen and various synthetic polymers as are described, for example,in Francis et al., U.S. Pat. No. 10,617,787, issued Apr. 14, 2020, andentitled “Biopolymer Compositions, Scaffolds and Devices,” the entiredisclosure of which is incorporated herein by reference, and Francis etal., U.S. Pat. No. 10,653,817, issued May 19, 2020, and entitled “Methodfor Producing an Implantable Ligament and Tendon Repair Device,” theentire disclosure of which is incorporated herein by reference.

The handle includes a slider member coupled to components thatfacilitate releasing the implant once it has been placed in a desiredposition in the body of the patient. The slider member and relatedcomponents are described in further detail below and shown.

The deployment device may be designed to be easily held. To this end,the body may include a handgrip portion. The handgrip portion may bedesigned to accommodate either a left or right hand. A user's hand mayengage the handgrip portion and use their fingers to actuate the slidermember. Additionally, a user's finger(s) or thumb can be used to movethe slider member. It may be appreciated that in some embodiments, avariety of different materials, coatings and/or surface treatments canbe used with the handle and/or the slider member to improve grip andprevent slipping.

In some embodiments, the disclosed implant delivery device may beconfigured for insertion through a medical cannula. Medical cannulas aregenerally well-known in the art of arthroscopic surgery. For example,various types of cannulas are used to control the inflow or outflow offluids, to allow access for tools into the tissue, and for otherfunctions. In some types of surgeries, an implant or other substratematerial may be introduced into a surgical site through a cannula, whichmaintains an enlarged access port to the surgical site. Additionally,many arthroscopic surgeries, such as joint surgeries, use pressurizedirrigation fluid to keep tissue separated apart from other tissue. Inparticular, pressurized irrigation fluid may be used to aid invisualization of the surgical site as well as to prevent bleeding fromvasculature surrounding the surgical cuts. Other types of surgeries,such as gastrointestinal procedures, use pressurized gas to provideaccess to and visualization of the surgical site.

Utilizing a cannula eliminates the need to include an outer sheathcovering the implant during insertion. That is, if the implant isinserted through an incision in the bare skin of the patient, theimplant, which is typically relatively delicate, is typically preferredto be encased. Accordingly, implant delivery devices configured tointroduce implants directly through the skin (i.e., without a cannula)typically include a sheath that covers the implant during insertion andwhich is then retracted to expose the implant once the distal end of theinstrument reaches the surgical site. Alternatively, devices may includea fixed outer sheath and a movable inner component that holds theimplant within the sheath during insertion and is then moved distally toexpose the implant at the surgical site.

The presently disclosed implant delivery device is devoid ofimplant-covering sheathes. Instead, the disclosed device includesresilient implant supporting flange members that pinch the implantgenerally along a midline of the implant. The flange members abutagainst a partial area of both sides of the implant. The resilientflange members thus bias the implant toward an unfurled configuration.However, because both the implant and flange members are flexible, theimplant (and flange members) may roll up when delivered through asurgical cannula. When the distal end of the device exits the distal endof the cannula, the flange members bias the implant into an unfurledcondition. The implant can then be positioned over the tendon and/orbone at the surgical site. In addition, the implant delivery device canbe used to hold the implant in place while anchors are used to securethe implant to the native tissue/bone.

FIG. 3 is a schematic illustration of an implant delivery deviceaccording to an embodiment holding an implant prior to delivery throughan illustrated access cannula. As shown in FIG. 3, an implant deliverydevice 300 may be configured to be inserted through a cannula 305. Asfurther shown in FIG. 3, implant delivery device 300 may have a proximalend 310 and a distal end 315. In addition, implant delivery device 300may include a handle 320 disposed at proximal end 310 of implantdelivery device 300 and configured to be grasped by a user.

Implant delivery device 300 may include an implant holding portion 325proximate distal end 315 of implant delivery device 300, implant holdingportion 325 being configured to retain a sheet-like implant 330 duringimplantation of implant 330.

Handle 320 may include a casing 335 including a slider member 340configured to actuate an implant release mechanism discussed in greaterdetail below. In some embodiments, handle 320 may include anambidextrous configuration. For example, as shown in FIG. 3, slidermember 340 may include a first slider 342 and a second slider 345. Asshown in later FIGS. (see, e.g., FIG. 18), first slider 342 may beattached to or integral with second slider 345. Thus, actuating eitherslider will have the same effect. Accordingly, a surgeon can use eitherhand and hold the device in a variety of orientations and still haveready access to slider member 340.

Casing 335 of handle 320 may be formed of a substantially rigidmaterial, such as a hard/rigid plastic and/or metal. Casing 335 mustsubstantially maintain its shape and structural integrity duringmanipulation of implant delivery device 300 as handle 320 is the portionof the device to which forces are applied during use. Further, theconnection between handle 320 and outer shaft 390 must be configured towithstand this loading.

As shown in FIG. 3, exemplary cannula 305 may have a proximal end 350with a wider mouth opening and a narrower distal portion 355 includingthreads 360. Cannula 305 may include a tapered intermediate portion 365between proximal end 350 and distal portion 355. Implant delivery device300 may be configured such that, when passing implant 330 throughcannula 305, tapered intermediate portion 365 may roll up implant 330.As further shown in FIG. 3, cannula 305 may include a seal structure370. Seal structure may include a seal 375. Seal 375 may be any type ofseal suitable for passing instruments, such as obturators through. Forexample, as shown in the accompanying figures, seal 375 may be aduckbill valve. In other embodiments, seal 375 may be a tricuspid valve.In some embodiments, seal structure 370 may include more than one sealin series. In addition, seal structure 370 may include a tether 380 forconnecting seal structure 370 to cannula 305. Further, seal structure370 may include a grasping tab 385. It will be understood that cannula305 and seal structure 370 may have any suitable configurations forpassing implants therethrough using implant delivery device 300. Implantdelivery device 300 may be configured for use with cannulas having anyof the features disclosed in Jones et al., U.S. patent application Ser.No. 17/173,531, filed Feb. 11, 2021, and entitled “Surgical Cannula withRemovable Pressure Seal,” the entire disclosure of which is incorporatedherein by reference.

Further, implant delivery device 300 may include an outer shaft 390extending from handle 320 to distal end 315 of implant delivery device300. Outer shaft 390 may be formed out of a substantially rigid materialthat is also biocompatible. For example, outer shaft 390 may be formedout of surgical stainless steel or titanium. In some embodiments, outershaft 390 may be formed to have substantially no deflection whensubjected to the forces of implant delivery. In other embodiments, outershaft 390 may be configured to have a predetermined amount offlexibility in order to facilitate placement of the implant viamanipulation of the handle. It will be understood that, alsocontemplated are configurations where the implant is not necessarilyattached to a shaft, but attached to an alternative structure at thedistal end of the device.

In addition, as shown in FIG. 3, implant delivery device 300 may furtherinclude a cannula sealing member 400 disposed about a midportion ofouter shaft 390. Cannula sealing member 400 may include a proximalflange 405 for abutting proximal end 350 of cannula 305. In addition,cannula sealing member 400 may include a narrower distal portion 410configured to fit within narrow distal portion 355 of cannula 305.Distal portion 410 of cannula sealing member 400 may include one or moreribs 415 configured to seal against the inner wall of distal portion 355of cannula 305. In addition, cannula sealing member 400 may include atapered intermediate portion 420 between proximal flange 405 and narrowdistal portion 410.

When implant insertion device 300 is to be inserted through cannula 305,seal structure 370 may be removed from proximal end 350 of cannula 305.In order to maintain pressure at the surgical site, cannula sealingmember 400 may be inserted into cannula 305 as implant delivery device300 is passed through cannula 305. Cannula sealing member 400 may beslidable along outer shaft 390 of implant insertion device 300 in orderto facilitate manipulation of implant insertion device 300 to and aboutthe surgical site.

As also shown in FIG. 3, outer shaft 390 of implant delivery device 300may include a ring 425 disposed distal to cannula sealing member 400 andconfigured to pull cannula sealing member 400 out of cannula 305 whenhandle 320 of implant delivery device 300 is pulled in the proximaldirection to withdraw implant delivery device 300 from the surgicalsite.

FIG. 4 is an enlarged schematic view of an implant holding portion ofthe implant delivery device holding an implant. In particular, as shownin FIG. 4, implant holding portion 325 may include a recess 450configured to receive implant 330, a fixed implant supporting flangemember 435 disposed within recess 450 and configured to support implant330 on one side, and a movable implant supporting flange member 440.Fixed implant supporting flange member 435 may be fixedly attached toouter shaft 390 within recess 450. Movable implant supporting flangemember 440 may be configured to be slidable between a first, distalposition and a second, proximal position. In the first, distal position,movable implant supporting flange member 440 is disposed within recess450 and secures implant 330 against fixed implant supporting flangemember 435, thus holding implant 330 in recess 450 in an unfurledconfiguration, as shown in FIG. 4. It will be noted that, although theflange members are not as large as the implant, the partial supportprovided by the smaller flange members is enough to maintain the implantin a substantially unfurled condition. Depending on the type of implantwith which the device is to be used, and the relative stiffness of theimplant, the flange members may vary in stiffness and/or size. Inaddition, the distance between the flange members may vary depending onthe thickness of the implant and the relative compressibility of theimplant in order to ensure suitable clamping force between the flangemembers.

Fixed implant supporting flange member 435 and movable implantsupporting flange member 440 may be formed of a flexible but resilientmaterial. That is, the material may be able to flex relatively easily,but return to the flat configuration when the loading is removed.

In addition, since fixed implant supporting flange member 435 andmovable implant supporting flange member 440 are exposed to the surgicalsite, they may be formed of a biocompatible material. Such biocompatibleplastics may include the following: polyethylene, polypropylene,polyimide (Kapton®), acrylonitrile butadiene styrene and PAEK polymers.In some embodiments, implant supporting flange members formed of suchmaterials may have thicknesses of approximately 0.001 to 0.025 inch.Other possible materials for the flange members may include nitinol,stainless steel, and/or titanium. Implant supporting flange membersformed of such metallic materials may be formed in the appropriatethickness to match the properties of flange members formed of thenon-metal materials mentioned above.

As also shown in FIG. 4, movable implant supporting flange member 440may be attached to an inner shaft 430, which may be translated in theproximal and distal directions to slide movable implant supportingflange member 440. Further, distal end 315 of implant delivery device300 may include a recess 445 at the end of outer shaft 390 for receivinga distal tip of inner shaft 430. Since at least a portion of inner shaft430 is exposed to the surgical site, inner shaft 430 may also be formedof a biocompatible material, such as surgical stainless steel ortitanium.

In addition, as also shown in FIG. 4, a distal wall 455 of recess 450may be beveled. This bevel may facilitate release of implant 330, andremoval of implant delivery device 300 from the surgical site as it iswithdrawn across a delivered implant. That is, when removing implantdelivery device 300, the bevel of distal wall 455 may enable outer shaft390 to slide past implant 330 without catching on an edge of implant330.

FIG. 5 is another schematic view of implant delivery device 300 holdingimplant 300 prior to delivery through cannula 305. Panel 335 (FIG. 3) isremoved in FIG. 5 in order to expose the inner mechanics of handle 320.Slider member 340 may be configured to be moved in the proximal anddistal directions in order to slide movable implant supporting flangemember 440 between the first, distal position discussed above and shownin FIG. 5 (as well as FIGS. 3 and 4) and a second, proximal position(shown in FIG. 16 and discussed in further detail below) wherein movableimplant supporting flange member 440 is withdrawn from the recess inouter shaft 390 (see recess 445, shown in FIG. 4), thus enabling releaseof implant 330 from the recess.

It will be understood that, in some embodiments, the sliding movement ofthe movable implant supporting flange member may be opposite. That is,the movable flange member may be slid in the distal direction to releasethe implant. In still other embodiments, the movable implant supportingflange member may be moved in an alternative non-sliding manner torelease the implant. For example, in some embodiments, the movableimplant supporting flange member may be moved with respect to the fixedimplant supporting flange member in a clamshell type action. In somecases, the clamshell opening may occur at the proximal end or distal endof the implant. In other cases, the clamshell opening may be at onelateral side of the implant or the other.

FIG. 5 also includes an enlarged view of the implant holding portion ofimplant delivery device 300. In this view, FIG. 5 shows movable implantsupporting flange member 440 disposed against implant 330, preventingimplant 330 from being released. FIG. 5 also shows inner shaft 430extending through outer shaft 390 and connecting slider member 340 inhandle 320 to movable implant supporting flange member 440 at the distalend of implant delivery device 300.

FIGS. 6-7 are schematic views showing the implant being inserted throughthe cannula. FIG. 6 shows cannula 305 in phantom in order to reveal theimplant holding portion of implant delivery device 300 along withimplant 330 being passed through cannula 305. As shown in FIG. 6, andmore clearly shown in FIG. 7, implant 330 may roll up when being passedthrough cannula 305.

It will be understood that the fixed implant supporting flange member(435; FIG. 4) and the movable implant supporting flange member (440;FIG. 4) are flexible and resilient such that the fixed implantsupporting flange member and the movable implant supporting flangemember may be collapsed/deflected upon delivery through cannula 305. Insome cases, as shown in FIG. 7, the flange members and implant 330 mayroll up in order to facilitate passage of implant 330 through cannula305 and to provide protection for implant 330 during this passage. Itwill be understood, however, that the implant and the flange members mayfold, wrinkle, or otherwise collapse in a uniform or non-uniform mannerupon insertion through the cannula. In other words, the implant and theflange members may have a constrained condition or form in which theseelements are at least partially collapsed, and an unconstrainedcondition or form in which these elements are substantially unfurled.The collapsed/constrained condition may occur in situ, as the surgeonpasses the distal end of the delivery device with the implant through acannula. This collapsed/constrained condition may be a “non-use”condition of the implant, whereas the (substantially) unfurled conditionmay be a “use” condition.

FIG. 8 is a schematic view of the implant being rolled up as it isduring delivery through the cannula, but with the cannula removed forpurposes of illustration. As shown in FIG. 8, not only is implant 330collapsed, but fixed implant supporting flange member 435 is alsocollapsed along with implant 330. Although inside the collapsed implant330, movable implant supporting flange member (440) is also collapsed.

FIG. 9 is a schematic view of the implant delivery device extendingthrough the cannula with the cannula sealing member seated within thecannula and with the implant unfurled after exiting the cannula. Inparticular, FIG. 9 shows implant holding portion 325 of implant deliverydevice 300 extending beyond the distal end of cannula 305. Accordingly,implant 330 is unfurled in this position, since the cannula is no longersurrounding implant 330 to keep it rolled up.

FIG. 9 also shows cannula sealing member 400 seated within cannula 305.In this configuration of the components, pressure may be maintainedwithin the surgical site and the implant is ready to be anchored to thetissue/bone and then released from implant holding portion 325 ofimplant delivery device 300.

FIG. 10 is a schematic view of the implant delivery device with animplant supporting flange member partially withdrawn part way throughthe process of releasing the implant. As shown in FIG. 10, slider 340has been moved proximally a portion of its permitted travel.Accordingly, inner shaft 430 has moved proximately, thus sliding theattached movable implant supporting flange member 440 in the proximaldirection. It will be noted that there are not necessarily any detentsthat stop the mechanism at this stage of withdrawal. This is anintermediate condition illustrated simply to facilitate demonstration ofthe process of withdrawing movable implant supporting flange member 440.

FIG. 11 is an enlarged schematic view of the implant holding portion ofthe implant delivery device with the implant supporting flange memberpartially withdrawn, as shown in FIG. 10. As illustrated in FIG. 11,inner shaft 430 is partially withdrawn, as is movable implant supportingflange member 440 attached thereto. In this condition, the distal halfof implant 330 is no longer supported on both sides. Again, thisintermediate condition is merely shown for purposes of illustrating thetranslation of movable implant supporting flange member 440.

FIG. 12 is another enlarged schematic view of the implant holdingportion of the implant delivery device with the implant supportingflange member partially withdrawn. FIG. 12 shows recess 445 into whichthe distal end of inner shaft 430 is disposed when movable implantsupporting flange member 440 is in the distal (i.e., implant holding)position.

FIG. 13 is another enlarged schematic view of the implant holdingportion of the implant delivery device with movable implant supportingflange member 440 partially withdrawn and with implant 330 shown inphantom in order to illustrate fixed implant supporting member 435 underimplant 330. FIG. 13 illustrates how fixed implant supporting flangemember 435 remains in place, fixed to outer shaft 390 and movableimplant supporting flange member 440 has been moved proximally relativeto fixed implant supporting flange member 435.

FIG. 14 is an enlarged schematic view of the implant holding portion ofthe implant delivery device with the implant supporting flange memberpartially withdrawn and with the implant omitted in order to illustratethe relationship between the two implant supporting flange members.Again, fixed implant supporting flange member 435 remains in place atthe distal end of implant delivery device 300 and movable implantsupporting member 440 has been moved proximally relative to fixedimplant supporting flange member 435 and outer shaft 390. In order tofacilitate this movement of movable implant supporting flange member440, outer shaft 390 may include a slot 1400. As shown in FIG. 14, outershaft 390 may include slot 1400 into which movable implant supportingflange member 440 is slid when inner shaft 430 is moved in the proximaldirection.

FIG. 15 is a schematic views of an inner shaft and a movable implantsupporting flange member held therein. As shown in FIG. 15, inner shaft430 may include a slit 1500 in which movable implant supporting flangemember 440 is disposed. Movable implant supporting flange member 440 maybe snugly fitted within slit 1500 so that movable implant supportingflange member 440 moves when inner shaft 430 is moved. In addition, thedistal tip of inner shaft 430 may include a beveled end 1505 in order tofacilitate insertion of this distal tip into the recess (445; FIG. 4) atthe distal end of outer shaft 390.

In order to fully release the implant from the recess in the outershaft, the inner shaft is retracted further, completely withdrawing themovable implant supporting flange member from the recess. FIG. 16 is aschematic view of the implant holding portion of the implant deliverydevice with the implant supporting flange member fully withdrawn andwith the implant released from the implant delivery device. A shown inFIG. 16, movable implant supporting flange member 440 has been movedfurther proximally and no longer overlaps with fixed implant supportingflange member 435. Accordingly, implant 330 is released from recess 450in outer shaft 390 of implant delivery device 300.

Once implant 330 is secured at the surgical site and released, implantdelivery device 300 may be removed from the surgical site throughcannula 305. FIG. 17 is a schematic view of implant delivery device 300being withdrawn through cannula 305 after having delivered implant 330.FIG. 17 further shows slider member 340 in its most proximal locationhaving been slid proximally to fully retract the movable implantsupporting flange member (440; FIG. 16). In addition, FIG. 17 also showscannula sealing member 400 partially withdrawn from cannula 305.

FIG. 18 is a schematic view of the handle of the implant delivery devicewith an outer panel removed to reveal the inner components of thehandle. FIG. 18 is included to further illustrate the details of slidermember 340 and the attached inner shaft 430.

FIG. 19 is a schematic view of the implant delivery device beingwithdrawn through the cannula with the cannula shown in phantom toreveal the ring on the outer shaft of the implant delivery devicepulling the cannula seal member out of the cannula. As shown in FIG. 19,ring 425 on outer shaft 390 is abutted against the distal end of cannulasealing member 400. Accordingly, because of the positioning of ring 425,withdrawal of outer shaft 390 through cannula 305 unseats cannulasealing member 400 from cannula, permitting full removal of implantdelivery device 300 without cannula sealing member 400 remaining stuckwithin cannula 305 and sliding off the end of outer shaft 390.

FIG. 20 is a flowchart illustrating a method of delivering a sheet-likeimplant to a surgical site using the implant delivery device shown anddiscussed with respect to FIGS. 3-19. As shown in FIG. 20, the method ofdelivering the implant may include inserting a cannula into an incisionin the skin of a patient. (Step 2000.) In some embodiments, the methodmay include placing a sheet-like implant into the implant holdingportion of the implant delivery device. However, in other embodiments,this process of loading the implant into the implant delivery device maybe done as a manufacturing step, and the loaded implant delivery devicemay be provided to the surgeon ready for use.

In addition, once the cannula is inserted, the method may also includearthroscopically inserting the implant holding portion of the implantdelivery device through the cannula to a surgical site. (Step 2005.) Itwill be noted that, in some cases, the implant delivery device may beused in non-arthroscopic (e.g., open) surgeries. It will be furthernoted that the disclosed implant delivery device need not necessarily beused with a cannula such as cannula 305. If the implant delivery devicewere to be used during an open surgery, the cannula would not benecessary.

The next step in the method involves the securing of the implant totissue/bone at the surgical site, for example, with one or more anchors.(Step 2010.) Once the implant has been secured, the movable implantsupporting flange member may be moved to the proximal position (bymoving the slider member in the proximal direction) allowing the implantto be released. (Step 2015.) Finally, once the implant has beenreleased, the instrument (i.e., the implant delivery device) may beremoved from the surgical site. (Step 2020.)

While various embodiments are described, the description is intended tobe exemplary, rather than limiting and it will be apparent to those ofordinary skill in the art that many more embodiments and implementationsare possible that are within the scope of the disclosed embodiments.Although many possible combinations of features are shown in theaccompanying figures and discussed in this detailed description, manyother combinations of the disclosed features are possible. Any featureor element of any embodiment may be used in combination with orsubstituted for any other feature or element in any other embodimentunless specifically restricted. Further, unless otherwise specified, anystep in a method or function of a system may take place in any relativeorder in relation to any other step described herein.

What is claimed is:
 1. An implant delivery device, comprising: a handledisposed at a proximal end of the implant delivery device and configuredto be grasped by a user; and an outer shaft extending from the handle toa distal end of the implant delivery device; the implant delivery deviceincluding an implant holding portion proximate the distal end of theimplant delivery device, the implant holding portion being configured toretain a sheet-like implant during implantation of the implant; and theimplant holding portion being configured to receive the implant betweena fixed implant supporting flange member associated with the outer shaftand configured to support the implant on one side, and a movable implantsupporting flange member; wherein the movable implant supporting flangemember is configured to be slidable between a first, distal position anda second, proximal position; wherein, in the first, distal position, themovable implant supporting flange member secures the implant against thefixed implant supporting flange member, thus holding the implant in anunfurled configuration; and wherein, in the second, proximal position,the movable implant supporting flange member is withdrawn from thedistal end of the implant delivery device, thus enabling release of theimplant.
 2. The implant delivery device of claim 1, wherein the fixedimplant supporting flange member and the movable implant supportingflange member are flexible and resilient such that the fixed implantsupporting flange member and the movable implant supporting flangemember may be collapsed upon delivery through a cannula.
 3. The implantdelivery device of claim 1, further including a cannula sealing memberdisposed about a midportion of the outer shaft.
 4. The implant deliverydevice of claim 3, wherein the outer shaft includes a ring disposeddistal to the cannula sealing member and configured to pull the cannulasealing member out of the cannula when the handle of the implantdelivery device is pulled in a proximal direction.
 5. The implantdelivery device of claim 1, wherein the handle includes a slider memberconfigured to be moved in the proximal and distal directions in order toslide the movable implant supporting flange member between the firstposition and the second position.
 6. The implant delivery device ofclaim 5, further including an inner shaft extending through the outershaft and connecting the slider member in the handle to the movableimplant supporting flange member at the distal end of the implantdelivery device.
 7. The implant delivery device of claim 6, wherein theinner shaft includes a slit in which the movable implant supportingflange member is disposed.
 8. The implant delivery device of claim 7,wherein the outer shaft includes a slot into which the movable implantsupporting flange member is slid when the inner shaft is moved in theproximal direction.
 9. The implant delivery device of claim 1, wherein adistal wall of the recess is beveled.
 10. An implant delivery device,comprising: an implant holding portion proximate a distal end of theimplant delivery device, the implant holding portion being configured toretain a sheet-like implant during implantation of the implant; theimplant holding portion being configured to receive the implant with amovable implant supporting flange member configured to retain theimplant; wherein the movable implant supporting flange member isconfigured to be movable between a first position in which the movableimplant supporting flange member holds the implant within the recess anda second position in which the implant is unencumbered by the movableimplant supporting flange member, thus enabling release of the implantfrom the implant holding portion of the implant delivery device.
 11. Theimplant delivery device of claim 10, wherein the fixed implantsupporting flange member and the movable implant supporting flangemember are flexible and resilient such that the fixed implant supportingflange member and the movable implant supporting flange member may be atleast partially collapsed upon delivery through a cannula.
 12. Theimplant delivery device of claim 10, wherein the implant is retained ina recess by the movable implant supporting flange member and the fixedimplant supporting flange member.
 13. A method of delivering asheet-like implant to a surgical site, comprising: providing an implantdelivery device with a sheet-like implant secured by an implant holdingportion of the implant delivery device such that the implant is heldwith respect to an outer shaft and between a fixed implant supportingflange member and a movable implant supporting flange member; insertingthe implant holding portion of the implant delivery device to a surgicalsite; moving the movable implant supporting flange member to a secondposition, thereby allowing the implant to be released.
 14. The method ofclaim 13, further including inserting the outer shaft of the implantdelivery device through an access cannula disposed in an incision in apatient's skin.
 15. The method of claim 14, wherein the fixed implantsupporting flange member and the movable implant supporting flangemember are flexible and resilient such that the fixed implant supportingflange member and the movable implant supporting flange member, and theimplant have an original unconstrained form, are at least partiallycollapsed upon delivery through the cannula, and return substantially tothe original unconstrained form upon exiting the cannula.
 16. The methodof claim 13, further including inserting a cannula sealing memberdisposed about a midportion of the outer shaft into the cannula.
 17. Themethod of claim 16, further including withdrawing the implant deliverydevice through the cannula, wherein the outer shaft includes a ringdisposed distal to the cannula sealing member, and wherein, when theimplant delivery device is withdrawn through the cannula, the ring pullsthe cannula sealing member out of the cannula.
 18. The method of claim13, wherein the handle includes a slider member, and wherein moving themovable implant supporting flange member is performed by moving theslider member in the proximal direction.
 19. The method of claim 18,wherein the implant delivery device includes an inner shaft extendingthrough the outer shaft and connecting the slider member to the movableimplant supporting flange member.
 20. The method of claim 19, whereinthe outer shaft includes a slot into which the movable implantsupporting flange member is slid when the inner shaft is moved in theproximal direction.